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St Jude Medical recalls St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Recalled November 12, 2014 · FDA recall Z-0177-2015 · St Jude Medical
Hazard
St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue · FDA Class II
Units
26
Sold at
US Distribution including the states of CA, GA, NJ, NY, OR and PA.
Description
St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
Product
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Manufacturer(s)
St Jude Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →